Biosimilars are subsequent entry versions of a Canadian-approved innovator biologic. The table below provides an overview of biosimilars approved by Health Canada.
Canada’s intellectual property regimes, including patents, data protection, certificates of supplementary protection and the patent-linkage regime of the Patented Medicines (Notice of Compliance) Regulations, protect innovator biologic products in Canada. Smart & Biggar is committed to protecting innovation in life sciences, and our lawyers can offer specialized advice on industry-specific aspects of IP law and related regulatory areas impacting biologics and biosimilars. Please contact our Life Sciences Regulatory & Compliance and Pharmaceutical Litigation team with any questions.
Note: italicized products are not yet marketed. This table is updated on a regular basis. Current as of March 28, 2023.
* Review time calculated from the date of filing to the earlier of the date approval and IP hold, where available.
(month of approval)
- Review time*
- Medicinal ingredient
- Reference biologic